Your browser does not support JavaScript! LEADER EXTRA STRENGTH MEDICATED PAIN RELIEF PATCH (MENTHOL) PATCH [CARDINAL HEALTH]
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LEADER EXTRA STRENGTH MEDICATED PAIN RELIEF PATCH (menthol) patch
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient                                         Purpose

Menthol 5%.............................................. Topical analgesic

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings

For external use only

If pregnant or breast-feeding, ask a health professional before use.

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if:

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years old
  • peel off protective backing and apply sticky side to affected area
  • should be used up to 8 hours
  • should be used no more than 3 times a day
  • children under 12 years of age consult a doctor

Other information

  • store at room temperature, not to exceed 85°F (30°C)

Inactive ingredients

1,3-butylene glycol, aloe vera (powder), dibutylhydroxytoluene, disdoium edate, d-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminum hydrate, metacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium oxide, tocopherol acetate

DISTRIBUTED BY:

CARDINAL HEALTH

DUBLIN, OHIO 43017 USA

image description

LEADER EXTRA STRENGTH MEDICATED PAIN RELIEF PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49781-083
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
1,3-BUTYLENE GLYCOL 
ALOE VERA FLOWER 
EDETATE DISODIUM 
GELATIN 
GLYCERIN 
KAOLIN 
PARAFFIN 
ALUMINUM HYDROXIDE 
POLYSORBATE 80 
WATER 
SORBITAN MONOOLEATE 
TARTARIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-083-701 in 1 BOX
11 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/25/2014
Labeler - Cardinal Health (097537435)

Revised: 3/2014
 
Cardinal Health

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